The bill aims to stop branded drug manufacturers from delaying the introduction of generic drugs.
The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was recently introduced in hopes of potentially increasing access to generic drugs.
The bill was introduced by both Democratic and Republican Senators who hope to stop pharmaceutical companies from limiting access to generics for financial gains.
The Hatch-Waxman Act was created to expedite the approval process for generics, but it was recently discovered that drug manufacturers have been using the law to delay the process through Risk Evaluation and Mitigation Strategies (REMS), according to a statement given by Sen Chuck Grassley (R-IA) at the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights.
Due to the actions of these branded companies, many generic drugs have been blocked, resulting in higher drug costs. Manufacturers are required to test their generic drug against the branded drug to ensure safety and efficacy.
This process cannot be completed without samples for testing, thus delaying the manufacturing of generic drugs. These branded companies have also been refusing to agree on a single safety protocol for the drug, which is required by the FDA.
“I want to make sure that consumers can enjoy the benefits of drug competition — more choice and lower prices for their lifesaving drugs,” Sen Grassley said at the subcommittee. “The CREATES Act will help do just that.”
The bill has received support from the National Association of Chain Drug Stores, Express Scripts, the Generic Pharmaceutical Association, the Biosimilars Council, the Pharmaceutical Care Management Association (PCMA), and more, according to an article from Drug Store News.
"This legislation will help bring generics to market faster, which is key to reducing drug costs," said PCMA President and CEO Mark Merritt in a press release.
In the subcommittee, several US Senators expressed concern for the rising costs of prescription drugs, believing this bill could help patients receive treatment who may not be able to afford it otherwise.
“Pharmaceutical companies should be compensated for their important work developing lifesaving treatments. But when companies engage in predatory practices at the expense of consumers, we must act,” Sen Patrick Leahy (D-VT) said in the subcommittee. “Our bill creates a sensible, efficient way for generic drug manufacturers to address these delays without jeopardizing patient safety or creating protracted litigation in the courts.”